When developing a therapeutic for clinical use, technology transfer is a crucial step. This path is often made more challenging when the therapeutic is based on a relatively new technology whose regulation is still being defined, such as nanoparticles.
To navigate this terrain effectively, tapping into the expertise of seasoned regulatory, quality, and CMC personnel, along with collaborating with proficient CDMOs, proves instrumental in streamlining this complex aspect of clinical development.
Designed for the biopharma community, this white paper addresses:
- Solutions for common challenges that arise during the transfer of R&D processes to a new site for process development
- Why choosing the right partner for this complex and time-consuming stage of clinical development is critical to the success of your program
- How to develop a process and control strategy that will help you overcome the unique roadblocks of developing novel nanomedicine therapeutics